Hobson Prior are looking for a QA Specialist - Systems, Documentation & Training to join a top biotechnology organisation on a permanent basis in Stevenage. Our client concentrates on developing pioneering gene therapies to enable people living with chronic diseases live a better life.
Primarily responsible for handling PQS non-conformances, change controls, CAPAs and OOS system documentation.
Manage timely reviews and progression of non-conformance, change control, CAPA and OOS system documentation within the organisation.
Ensure that all systems used to monitor the progress of non-conformances, change controls, CAPAs and OOSs system documentation are maintained accurately.
Ensure that relevant line managers have visibility of pending/due non-conformances, change controls, CAPAs and OOSs system documentation.
Work alongside the QA Manager to deliver training for nonconformance, change control, CAPA and OOS system documentation.
Partake in the design of e-QMS workflows for non-conformances, change controls, CAPAs and OOSs system documentation.
Deliver guidance and direction to personnel on appropriate CAPAs.
Verify completion of CAPA actions.
Deputise for PQS Document Controller as required.
Excellent planning and organisational skills.
Ability to work in a small team in a dynamic environment.
Experience with biologics/ATMP.
Excellent interpersonal skills.
Excellent verbal and written communication.
Significant experience and/ or familiarisation with Microsoft Office applications (specifically Word and Excel).
Good understanding of QA principles, especially non-conformance, change control and CAPA systems.
Educated to degree level or equivalent.
Prior experience in the pharmaceutical industry, minimum three years QA experience.
Prior experience implementing an electronic QMS system would be advantageous.
If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.